MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0500

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report # (b)(4).Symptom: pump has intermittent high baseline alarms on patient.Pump was switched out quickly with no complications findings/action taken: replaced pump assy.Returning on (b)(4).Also perform peventative maintence (pm).Fcn level: (b)(4).Software level: 2.24 op = on patient confirmed.

Manufacturer Narrative

(b)(4) the reported alarm could not be replicated at teleflex (b)(4); however, excessive noise was noted and the pump alarmed system error 3 approximately 2 hours after initiating pumping.There was no reported patient injury or complications.Teleflex will continue to monitor for any developing trend.

Event Description

It was reported via a field service report # l611391.Symptom: pump has intermittent high baseline alarms on patient.Pump was switched out quickly with no complications findings/action taken: replaced pump assy.Returning on ar# (b)(4).Also perform preventative maintenance (pm).Fcn level: 1416, software level: 2.24, op = on patient, confirmed.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 3015 carrington mill blvd; morrisville, PA 27560 ; 6104783117
• MDR Report Key: 6080171
• MDR Text Key: 59225992
• Report Number: 1219856-2016-00249
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: 0001117068
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1